An initial leaflet may be provided prior to requesting informed consent from the patient. This can be combined with the general information leaflet that the patient receives when completing QoL questionnaires, or may be a separate brief document that is specifically given out during the consent process. In addition to describing the nature of randomised trials and discussing issues of relevance to consent, it should explain the reasons for evaluating QoL, and indicate what this involves. It should mention the frequency and timing of assessments.
If QoL is the primary endpoint in a trial it may be included as a condition on the patient consent form. Patients who are unwilling to contribute towards the primary endpoint of a trial should be ineligible for randomisation.
We will also ask you to fill in a form, which assesses your quality of life, before you receive treatment and at 3, 6, 12 and 24 months after your treatment starts. The quality of life questionnaire is a standard form that is used for other patients and allows us to compare quality of life across various diseases. Because of this, there are some questions that may not seem relevant to your disease and its treatment. However, please try to answer them all.
The Patient QoL Information Leaflet is a detailed document that the patient may take away for reference. It should introduce the reasons for using questionnaires, explain aspects of the QoL assessment, and attempt to answer queries that patients commonly ask. Figure 13.2 shows an example.
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